BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 1334647 · Received February 24, 2009

    Report

    Report Number
    1518293-2009-00044
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 9, 2009
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT AND FOUND THERE WAS NO POWER TO THE TABLE MONITORS, DUE TO FAILURE OF THE LF04 POWER SUPPLY. POWER SUPPLY REPLACED. FSE TESTED THE SYSTEM PER MAINTENANCE SECTION OF SERVICE MANUAL. ALL OPERATIONAL TESTS PASSED, WITH THE UNIT FULLY FUNCTIONAL. CUSTOMER RETURNED SYSTEM TO FULL SERVICE.

    Description of Event or Problem · 1

    IN 2009: CUSTOMER REPORTS BOTH MONITORS ON THE TABLE AND LF05 ARE DOWN. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-STANDARD UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK